1. Field of the Invention
The present invention relates to method and apparatus for duodenal intubation of a patient for administering nutrition into the small intestine, and, more particularly, to the selection and usage of permanent magnets to establish a traction force useful to advance the leading end of a catheter feeding tube along the stomach and through the pylorus and distal duodenum of the small intestine.
2. Description of the Prior Art
In the course of human illness there are many situations were the patient can not or will not eat food in the traditional manner to obtain needed nutrition which the patient must have or the healing process will not occur. Nutrients can be supplied to the patient through the use of a catheter. Modern science has developed numerous nutrients suitable for administering intravenously to a patient either peripherally in the arm or in some instances more centrally into a large vein in the neck. These nutrients can provide a high level of substance, even life saving for the patient whose intestinal tract is dysfunctional. However, problems can develop with intravenous introduction of the nutrition. The piercing of the skin to provide access for the small catheter to the vein, whether peripheral or central, also forms a route for infection to enter the body. Complications such as bleeding may occur and in instances where the catheter is placed centrally, the possibility exists to puncture the lung during the procedure of placing the catheter. The nutrients suitable for intravenous introduction have an extremely high cost which coupled with the potential for infection and other complications make it more desirable to supply the needed nutrition to the intestinal tract.
A known method for introducing nutrition to the intestinal tract is to supply the nutrition via a small tube introduced through a naris of the nose along the oesophagus through the stomach and beyond the pylorus into the duodenum of the small intestines. In FIG. 1 there is a pictorial illustration of anatomical configuration of the stomach and duodenum together common nomenclature identifying salient parts for reference purposes. The introduction of nutrients from the catheter to the duodenum adds to the patients immunity while the nutrients facilitate healing. Moreover, feeding a patient through the gut also prevents intestinal villi atrophy. Maintaining the intestinal villi intact prevents the translocation of bacteria from inside the gut of the patient to his blood stream.
When a catheter tube is advanced through the nose into the oesophagus and comes into the stomach, the tip of the catheter is no longer constrained to a course of travel as it was during movement along the nose and oesophagus. In contrast, the stomach cavity is large in a direction transverse to the direction of passage of bolus therein. Shown in FIG. 2 are three possible positions A, B and C for the leading part of a catheter D to assume upon entrance in the cavity of the stomach E. The cavity of the stomach merely contains the catheter tip as it is advanced but fails to constrain and guide for an intended course of travel to the pylorus. The flexible elasticity of the catheter usually allows a coiled configuration to be formed as shown in FIG. 3 as the catheter is advanced further into the stomach. The leading part of the catheter D is most likely to follow a return course of travel generally toward the oesophagus but following a path along the internal wall of the greater curvature of the body of the stomach. Continued introduction of the catheter moves the tip portion into the fundus where it executes a return course to the body of the stomach. It has been found that only about 10% of the attempted catheter placements using conventional placement techniques successfully negotiate the necessary course of travel in the stomach to the pylorus and thence to the duodenum. The incidence of successful placement of the catheter was usually a matter of random luck.
A common site to locate a misplaced catheter inside the stomach is at the fundus of the stomach. The anatomical configuration of the stomach can range from what is described as a hypotonic stomach to an atonic stomach. The variety to the size and configuration serves only to complicate the intubation of the patient. The tract of the catheter through the stomach must be made to follow the general J-shaped curvature of the stomach which becomes an extremely difficult procedure when the sole means available to control the catheter is the manipulation of the catheter at the entrance site through the patient's nose. Even after the stomach is traversed by the catheter tip, the tip must be advanced beyond the pyloric sphincter and into the duodenum before the introduction of nutrition since if the pyloric sphincter is not traversed by the catheter, a patient when lying flat and perhaps unconscious, might aspirate fluids from the stomach through the oesophagus to the lungs, leading to serious complications.
The tip of the catheter can be advanced along the stomach by peristaltic movement. Such movement may require three to five days and sometimes medication is necessary to irritate the stomach to increase the peristaltic movement. Serial X-rays, sometimes at twelve hour intervals, are necessary to verify the peristaltic movement of the catheter from the stomach through the pylorus to the duodenum. Not only is the patient exposed to frequent radiation of the incidence of X-rays, but also the time delay and added costs for the care and transporting the critically ill patient to a fluoroscope department or bring X-ray equipment to the patient are all undesirable.
The use of magnet flux in the placement of catheters and for a variety of purposes at a desired location is known in the art which includes the disclosures by U.S. Pat. No. 3,043,309 to McCarthy; U.S. Pat. No. 3,358,676 to Frei, et al.; U.S. Pat. No. 3,674,014 to Tillander; U.S. Pat. No. 3,794,041 to Frei et al.; U.S. Pat. No. 3,847,157 to Caillouette, et al.; U.S. Pat. No. 3,961,632 to Moossun; U.S. Pat. No. 4,077,412 to Moossun; and U.S. Pat. No. 4,809,713 to Grayzel. The McCarty U.S. Pat. No. 3,043,309 issued Jul. 10, 1962 describes the use of a localized magnetic field generated by an electrical magnet to manipulate a suction tube with a magnetic member at its tip through an intestinal obstruction under fluoroscopic visualization of the magnetic member. The use of an electromagnet is seen as essential because of the needed on/off control to allow turning it off while fluoroscopy radiation is used. Otherwise, the magnetic field generated by the electromagnet will distort any picture on the fluoroscopy screen or X-ray plate. The electrical magnet with its small pole surface area of about 11/4 square inches supply only a very localized depth of penetrating flux, thereby necessitating the use of fluoroscopy to capture the targeted magnetic member of the tube, all represent complex disadvantages. Moreover, the use of very strong electrical current in the order of 40 amperes through the coils of the electrical magnet which is applied to the patient represent an unwarranted risk and hazard. The remaining patents show a variety of instructions for the inclusions of a magnet in a catheter. The Frei U.S. Pat. No. 3,794,041 shows beads of magnetic material inserted in a body part with the catheter for moving the body part using an external magnet. The Caillouette U.S. Pat. No. 3,847,157 shows the use of a magnetic indicator in a medico-surgical tube used to identify the location of the tube. The Tillander U.S. Pat. No. 3,674,014 shows a tip portion of a catheter made of tandemly arranged magnetic sections with ball shaped ends so that the sections can deflect with respect to each other for guidance of the catheter tip. The Moossun U.S. Pat. No. 4,077,412 shows a trans-abdominal stomach catheter of the Foley type used to direct the placement of the catheter by way of an external puncture from the outside of the abdomen through the stomach wall. The Frei et al, U.S. Pat. No. 3,358,676 shows the use of magnets and for remotely controlling propulsion of a magnet through a duct of a human being to perform a function upon activation such as to effect a release of drugs at a predetermined location. The Grayzel U.S. Pat. No. 4,908,713 shows the use of a catheter for use for electrically pacing or excitation of the heart.
The need therefore exists to provide a method and apparatus for duodenal intubation of a patient to provide nutrition to the digestive tract beyond the stomach which will overcome the shortcomings and disadvantages of known intubation procedures.
It is an object of the present invention to provide a method and apparatus for duodenal intubation of a patient for duodenal intubation of a patient using an external hand-held permanent magnet having a pole face approximating the anatomic width of the stomach of the patient which can be moved about the abdomen of a patient to establish a flux coupling with a permanent magnet in the tip of a catheter of a magnitude sufficient to impart a traction force to the catheter for advancement along the stomach through the pylorus to the duodenum.
It is a further object of the present invention to provide a method and apparatus for duodenal intubation of a patient through the use of a permanent magnet having a physical size which can be grasped between the out-stretched fingers of a person's hand and provide a magnetic pole face sufficiently large that flux lines will permeate the abdomen of the patient and form a flux coupling with a magnet in the tip of an intubation catheter and impart a traction force thereto while resident in the stomach of a patient.